FDASeptember 26, 2023device
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Affected lots of product may experience technical distortions to a greater extent than expected.
What to do
FDA enforcement status: Ongoing
Brands named
path
UPCs
04260223142437201015201029
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)2025-11-06
- FDAMultichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema p...2025-10-17
- FDAMultichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum...2025-10-17
- FDANature's Path Organic Pumpkin Spice Waffles, 7 oz., UPC 0 5844959077 42023-10-19
- FDANature's Path Organic Dark Chocolate Chip Waffles, 7 oz., UPC 0 5844916701 32023-10-19
- FDAAuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP2023-09-26
- FDASENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2023-09-26
- FDASENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S22023-09-26
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